First U.S. Wavefront Procedure Approved for All Forms of Astigmatism
VISX announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to treat mixed astigmatism with the VISX CustomVue LASIK procedure.
The FDA approval allows for WaveScan diagnosis and CustomVue treatment of patients with mixed astigmatism. This approval is specifically for wavefront-guided LASIK for correction of mixed astigmatism from 1 to 5 D of cylinder.
The CustomVue procedure is now the only U.S. approved wavefront-guided laser treatment for myopic, hyperopic and mixed astigmatism.
Douglas Koch, M.D., of Baylor Vision at Baylor College of Medicine and principal investigator for the VISX mixed astigmatism clinical trial, stated, “The continued expansion of labeling for CustomVue allows me to treat more patients with what I believe is the very best procedure on the market today. Mixed astigmatism patients are especially challenging for ophthalmologists because their vision is often difficult to correct with glasses and contacts. The CustomVue treatment may give these patients the opportunity to see better than they could ever see with glasses or contacts.”
In order to perform VISX CustomVue Mixed Astigmatism treatments, physicians must complete the CustomVue Mixed Astigmatism Certification Course.
